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Updated March 27, 2015.
If your child has been diagnosed with depression, you may already be familiar with clinical research. In fact, your child may have even been presented with the opportunity to participate in clinical research.
Clinical research is a special kind of research that is patient-oriented. Investigators in the study are trying to learn about how diseases and disorders work in humans.
According to the National Institutes of Health (NIH), clinical research activities include developing new treatments or technologies to be tested in clinical trials, as well as epidemiological and behavioral studies, outcomes research, and health services research.
Safety and Monitoring
Clinical research is heavily regulated and monitored by various institutions. A study investigator must be approved to conduct clinical research, and must follow various rules throughout the study process to ensure the safety and ethical treatment of all participating patients. Depending on where research takes place, activities may be regulated and monitored by:
Clinical Trials
A clinical trial is a common type of clinical research activity, which may have been offered to your child for a specific type of illness or disorder, like major depressive disorder or bipolar I disorder.
A clinical trial is a specific type of research study that is designed to answer questions about biomedical or behavioral interventions. These interventions are typically a new medication, device (e.g., light box therapy), psychotherapy, counseling, or education technique developed to improve the lives of people living with a certain disorder, or aimed at preventing that disorder.
For example, a child with diagnosed major depressive disorder may be invited to participate in a clinical trial of a newly developed psychotherapy technique that is thought to reduce depressive symptoms in children.
Clinical trials investigating a new medication or device are divided into four progressive phases of testing:
Once the data has been collected and analyzed for each phase it is reviewed to ensure the safety of going on to the next phase of research. Additional phases are sometimes included to get more information when appropriate.
Clinical research activities are an important part of the advancement of the medical field and the improvement of quality of life for those living with disorders. However, choosing to enroll your child in clinical research is an important decision that the whole family should feel comfortable with.
Sources:
The National Institute of Health. Glossary of Terms for Human Subjects Protection and Inclusion Issues. Accessed: 05/31/2011. http://grants.nih.gov/grants/peer/tree_glossary.pdf
The National Institute of Health. Office of Human Subjects Research. Additional Protections for Children Involved as Subjects in Research. Subpart D. Accessed: May 30, 2011. http://ohsr.od.nih.gov/guidelines/45cfr46.html#subpartd
SD Edwards, MJ McNamee. Ethical Concerns Regarding Guidelines for the Conduct of Clinical Research on Children. Journal of Medical Ethics. 2005. 31: 351-354.
Updated March 27, 2015.
If your child has been diagnosed with depression, you may already be familiar with clinical research. In fact, your child may have even been presented with the opportunity to participate in clinical research.
Clinical research is a special kind of research that is patient-oriented. Investigators in the study are trying to learn about how diseases and disorders work in humans.
According to the National Institutes of Health (NIH), clinical research activities include developing new treatments or technologies to be tested in clinical trials, as well as epidemiological and behavioral studies, outcomes research, and health services research.
Safety and Monitoring
Clinical research is heavily regulated and monitored by various institutions. A study investigator must be approved to conduct clinical research, and must follow various rules throughout the study process to ensure the safety and ethical treatment of all participating patients. Depending on where research takes place, activities may be regulated and monitored by:
- Institutional Review Boards (IRB) - A board consisting of appointed committee members who review and monitor research activities.
- Sponsoring Agencies - An agency, often a biomedical corporation, will provide funds to researchers to perform research activities to test the company's own new products.
- Granting Agencies - Advocacy, charitable, or government agencies, such as the National Institutes of Mental Health or the National Cancer Institute, may provide researchers with a grant, or funds, to conduct independent research.
- Food and Drug Administration (FDA) - The FDA monitors research activities and adverse events (negative or unwanted occurrences) of all new and established drugs and medical devices.
- Drug Enforcement Agency (DEA) - The DEA may, in some cases, be involved in the review of research activities when drugs and medical devices are involved.
Clinical Trials
A clinical trial is a common type of clinical research activity, which may have been offered to your child for a specific type of illness or disorder, like major depressive disorder or bipolar I disorder.
A clinical trial is a specific type of research study that is designed to answer questions about biomedical or behavioral interventions. These interventions are typically a new medication, device (e.g., light box therapy), psychotherapy, counseling, or education technique developed to improve the lives of people living with a certain disorder, or aimed at preventing that disorder.
For example, a child with diagnosed major depressive disorder may be invited to participate in a clinical trial of a newly developed psychotherapy technique that is thought to reduce depressive symptoms in children.
Clinical trials investigating a new medication or device are divided into four progressive phases of testing:
- Phase I - A drug or intervention is tested on a small group of people to determine initial safety, the appropriate dose (if applicable), and any side effects of the new treatment.
- Phase II - A drug or intervention is tested on a larger group of humans to determine efficacy, or to see if the proposed treatment works as it is intended to work.
- Phase III - A drug or intervention is tested on a larger group of humans to compare it to a current accepted standard of care treatment.
- Phase IV - This phase occurs after the intervention receives approval to be marketed. This phase is tested on a large and widespread population to determine long-term effects and appropriateness for a large population.
Once the data has been collected and analyzed for each phase it is reviewed to ensure the safety of going on to the next phase of research. Additional phases are sometimes included to get more information when appropriate.
Clinical research activities are an important part of the advancement of the medical field and the improvement of quality of life for those living with disorders. However, choosing to enroll your child in clinical research is an important decision that the whole family should feel comfortable with.
Sources:
The National Institute of Health. Glossary of Terms for Human Subjects Protection and Inclusion Issues. Accessed: 05/31/2011. http://grants.nih.gov/grants/peer/tree_glossary.pdf
The National Institute of Health. Office of Human Subjects Research. Additional Protections for Children Involved as Subjects in Research. Subpart D. Accessed: May 30, 2011. http://ohsr.od.nih.gov/guidelines/45cfr46.html#subpartd
SD Edwards, MJ McNamee. Ethical Concerns Regarding Guidelines for the Conduct of Clinical Research on Children. Journal of Medical Ethics. 2005. 31: 351-354.
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